Requirement:

• Minimum of 10 years of experience in the healthcare industry with proven expertise in regulatory management, product registration, licensing, and supplier coordination, ensuring full compliance with local and international medical device standards.
• Lead regulatory strategy and compliance for new product launches in the Indonesian market, ensuring alignment with both local (Kemenkes) and international medical device regulations.
• Evaluate and interpret regulatory requirements related to medical devices, providing strategic recommendations to support business operations and product planning.
• Manage end-to-end product registration and licensing processes, ensuring timely submissions, approvals, and adherence to applicable standards and documentation.
• Liaise with government authorities and regulatory bodies to facilitate approvals, reporting, and compliance coordination for company activities and product portfolios.
• Oversee importation and supplier management, ensuring all products meet regulatory, quality, and documentation requirements while supporting smooth supply chain operations.
• Collaborate cross-functionally with internal teams to review product materials, support procurement, and maintain up-to-date regulatory knowledge and best practices across medical device categories.
• Highly adaptable, quick to learn, and driven by excellence known for loyalty, honesty, and innovative thinking in achieving organizational goals.
• Excellent in English, both spoken and written. A Bachelor’s degree in Pharmacy or a related scientific field is required, with preference for candidates experienced in the medical device or healthcare regulatory sector.